Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s

The information collection provisions in this guidance have been approved under OMB control number 0910-0120. This approval expires August 31, 2010. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.

For questions regarding this document contact the Premarket Notification (510(k)) Section at 301-796-5640. This document was corrected on November 17, 2005 to clarify recommendations about the user fee cover sheet, biocompatibility, clinical protocols, investigational device exemptions, and the 510(k) cover letter.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health

Office of Device Evaluation

Office of In Vitro Diagnostic Device Evaluation and Safety

Contains Nonbinding Recommendations

Preface

Public Comment:

Written comments and suggestions may be submitted at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated.

Additional Copies

Additional copies are available from the Internet. You may also send an e-mail request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the guidance or send a fax request to 301-847-8149 to receive a hard copy. Please use the document number (1567) to identify the guidance you are requesting.

Guidance for Industry and FDA Staff
Format for Traditional and Abbreviated 510(k)s

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

Introduction

The main focus of this document is to provide guidance on how to format an original submission for a Traditional or Abbreviated Premarket Notification Submission (510(k)). This guidance document provides only a general framework for the format and content of a Traditional or Abbreviated 510(k). It does not describe our recommendations for any specific device types1, Special 510(k)s2, or other types of documents, such as Premarket Approval Applications (PMAs) or Investigational Device Exemption Applications (IDEs).

FDA believes the recommendations in this guidance document for a Traditional or Abbreviated 510(k) will conserve FDA and industry resources and facilitate timely review. This guidance document only supplements other FDA guidance’s on the 510(k) program and specific device types. It is not a replacement for those documents.

As an alternative to the submission format described in this document, you may submit your 510(k) in the globally harmonized format described in the document entitled “Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices.” The document was developed by Study Group 1 (SG1) of the Global Harmonization Task Force (GHTF) and issued as a proposed document in October 2002. See the FDA guidance, A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures3 for a description of the FDA pilot program and the eligible device types.

If you choose to submit a 510(k) in the STED format, the information about Traditional 510(k)s in this document may help you prepare your STED submission. Appendix C shows the correlation between the sections recommended in this guidance and the STED format.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, a guidance describes the Agency's current thinking on a topic and should be viewed only as a recommendation, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance documents means that something is suggested or recommended, but not required.

The Least Burdensome Approach

We believe we should consider the least burdensome approach in all areas of device regulation. This guidance reflects our careful review of the relevant scientific and legal requirements and what we believe is the least burdensome way for you to comply with those requirements. However, if you believe that an alternative approach would be less burdensome, please contact us so we can consider your point of view. You may send your written comments to the contact person listed in the preface of this guidance or to the CDRH Ombudsman. Comprehensive information on CDRH's Ombudsman, including ways to contact him, can be found on the internet.

Background

This document supplements other FDA documents regarding the content requirements for a 510(k) submission. You should also refer to regulation 21 CFR 807 Subpart E and the section on our web site How to Prepare a 510(k) Submission.

Definitions

Each person who wants to market in the United States, a class I, II, or III device intended for human use, for which a PMA is not required, must submit a 510(k)to FDA at least 90 days before marketing unless the device is exempt from 510(k) requirements of the Federal Food Drug, and Cosmetic Act (the act) and does not exceed the limitations of exemptions in xxx.9 of the device classification regulation chapters (e.g., 862.9, 864.9). There is no specific 510(k) form. However, 21 CFR 807 Subpart E describes requirements for a 510(k) submission. This guidance recommends a format that will help you comply with those requirements.

A Premarket Notification (510(k)) is a type of premarket submission that is intended to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (21 CFR 807.92(a)(3)) that does not require PMA. In order to determine if a device is substantially equivalent (SE), FDA considers intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics, as applicable.

A 510(k) submitter/holder is the owner of the 510(k). Although a consultant or correspondent may submit the 510(k) on behalf of the 510(k) owner, that consultant or correspondent is not the 510(k) submitter/holder.

A legally marketed device, as described in 21 CFR 807.92(a)(3), is a device that was legally marketed prior to May 28, 1976, for which a PMA is not required, or a device which has been reclassified from class III to class II or I, or a device which has been found SE through the 510(k) process. The legally marketed device(s) to which the submitter claims equivalence is commonly known as the "predicate." Although devices recently cleared under 510(k) are often selected as the predicate to which equivalence is claimed, any legally marketed device may be used as a predicate

A Traditional 510(k) is the most common type of 510(k). In a Traditional 510(k), the submitter provides descriptive information about the indications for use and technology and, if not identical to the predicate, results of performance testing to demonstrate substantial equivalence.

An Abbreviated 510(k) provides an effective means of streamlining the review of data in a 510(k) through a reliance on one or more:

Chapter I. Sections in a Traditional or Abbreviated 510(k)

In a Traditional or Abbreviated 510(k), we recommend that you include the sections headings listed, preferably in the sequence below. In some instances, the information in a particular section may not apply to your device. In order to speed our reviews, we recommend you retain the section headings in the sequence listed. If you believe a section does not apply, we recommend you include the section and state “This section does not apply” or “N/A” under that heading. For example, if your device does not contain any software, we recommend you state this in Section 16 titled “Software.”

Medical Device User Fee Cover Sheet (Form FDA 3601)

CDRH Premarket Review Submission Cover Sheet

510(k) Cover Letter

Indications for Use Statement

510(k) Summary or 510(k) Statement

Truthful and Accuracy Statement

Class III Summary and Certification

Financial Certification or Disclosure Statement

Declarations of Conformity and Summary Reports

Executive Summary

Device Description

Substantial Equivalence Discussion

Proposed Labeling

Sterilization and Shelf Life

Biocompatibility

Software

Electromagnetic Compatibility and Electrical Safety

Performance Testing – Bench

Performance Testing – Animal

Performance Testing – Clinical

Other

This document describes the format we recommend for each of these sections and provides resources, such as regulations, guidance documents, internet links that will be useful in preparing the sections. The guidance documents or other resources referred to in the links may be revised over time, but the links will remain the same. Therefore, by following the links in this document, you will be directed to the most current information for each section.

Chapter II. Description of Each Section for Traditional or Abbreviated 510(k)s

In this chapter, we explain each section of a Traditional or Abbreviated 510(k) and include some resources for information.

Although the following 510(k) submissions are also exempt from user fees, we recommend you include a Medical Device User Fee Cover Sheet, and use it to indicate the type of exemption that applies in the case of 510(k) submissions:.

intended solely for pediatric use (a change in the intended use from pediatric use to adult use requires the submission of a new 510(k) in accordance with 21 CFR 807.81(a)(3); and an associated fee)

submitted by a state or Federal government entity (exempt from the FDA user fee unless the device is to be distributed commercially).

2. CDRH Premarket Review Submission Cover Sheet

3. 510(k) Cover Letter

We recommend that you include a 510(k) Cover Letter with your submission. See Appendix A for more information on the proposed and suggested content of the 510(k) Cover Letter. Appendix A describes key information that may be useful to FDA in the initial processing and review of the 510(k) submission. In contrast with the CDRH Premarket Review Submission Cover Sheet from Section 2, the 510(k) Cover Letter described in Section 3 is intended to be more descriptive of a 510(k) submission.

4. Indications for Use Statement

We recommend that you use this section to provide the indications for use statement, which is a document where you identify and describe the specific indications for use statement for the device(s) included in the 510(k) submission.

Your indications for use statement should be exactly the same as the indications for use listed throughout the rest of your 510(k) submission, including the indications for use in the device labeling. We recommend that you use the Indications for Use Statement Format (PDF File Size: 1.03MB). We believe that in order for FDA to adequately review your submission you should identify whether the device is intended for prescription use and/or over-the-counter use.

5. 510(k) Summary or 510(k) Statement

In accordance with 21 CFR 807.87(h), each 510(k) submission must include either a 510(k) Summary (21 CFR 807.92) or 510(k) Statement (21 CFR 807.93). We recommend that you use Section 5 to provide the 510(k) Summary or 510(k) Statement.

A 510(k) Summary provides a brief summary of the device included in the 510(k) and the supporting information. A 510(k) Statement is a certification that the 510(k) holder will provide a copy of the 510(k) submission, with certain exclusions, to any person within 30 days of a written request. Further information regarding the content of the 510(k) at Summary or 510(k) Statement.

6. Truthful and Accuracy Statement

In accordance with 21 CFR 807.87(k), all 510(k)s must include a statement certifying that all information submitted in the 510(k) is truthful and accurate and that no material fact has been omitted. This form may be obtained at "Premarket Notification Truthful and Accurate Statement". The submitter should sign and date the statement. The 510(k) holder rather than a consultant or correspondent working for the holder should sign the Truthful and Accuracy Statement.

7. Class III Summary and Certification

If your 510(k) is for a device type classified into class III for which we have not called for PMAs, it must contain a Class III Summary and Certification in accordance with 21 CFR 807.87(j) and 807.94. The Class III Summary and Certification provide a review of the risks and adverse events known and associated with the general category of devices into which the proposed device falls. We recommend that you use the Class III Summary and Certification format.

8. Financial Certification or Disclosure Statement

In accordance with 21 CFR 807.87(i), if you submit information from clinical studies, you must submit a financial certification and/or a disclosure statement for each clinical investigator who participated in your study. The following forms are available on our web site:

If you choose to rely on a recognized standard or a guidance for any part of the device design or testing, you may include either a:

declaration of conformity to the standard4 or summary report recommended in any relevant device-specific guidance; or

a statement that testing will be conducted and meet specified acceptance criteria before the device is marketed.

Because a declaration of conformity is based on results from testing, we believe you cannot properly submit a declaration of conformity until you have completed the testing the standard describes. For more information, please refer to section 514(c)(1)(B) of the act. Additional information regarding the use of declarations of conformity may be obtained at "Declaration of Conformity to a Recognized Standard".

10. Executive Summary

In this section of your 510(k), we recommend that you provide an executive summary of the 510(k), which should include a:

concise description of the device, including the indications for use and technology;

device comparison table; and

concise summary for any performance testing in the submission.

The description, although concise, should be sufficient to provide an overall understanding of the device. The device comparison table should outline the differences and similarities between your device and the predicate. We recommend that you also provide a discussion of how this comparison supports substantial equivalence. The summary for each performance testing section (i.e., sections 18, 19, and 20) should be sufficient to provide a broad understanding of the type of testing performed, the methods used, and your conclusion from the results.

11. Device Description

We recommend that you describe the performance specifications and include a brief description of the device design requirements in this section. We also recommend that you identify all models, as well as all accessories or components, included in the submission.

If diagrams, dimensions, tolerances, and/or schematics are useful to fully describe and characterize the device, we recommend that you include them for each device, accessory or component included in the 510(k) submission. We also recommend that you provide a list of all patient contacting components and their respective materials.

12. Substantial Equivalence Discussion

In the substantial equivalence section, we recommend that you identify the predicate and identify its trade name, model number, 510(k) submitter/holder, and 510(k) number, if available. You may choose to identify, compare, and test against more than one predicate, if, for example, your device has two features or indications not previously combined in a single predicate. Our substantial equivalence determination is based on the 510(k) Decision-Making Flowchart found in Appendix A of The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] guidance document.

We recommend that you provide a detailed comparison between your device and the predicate sufficient to demonstrate the substantial equivalence of the devices, as applicable, in terms of:

13. Proposed Labeling

The 510(k) must include proposed labeling in sufficient detail to satisfy the requirements of 21 CFR 807.87(e). If the device is an in vitro diagnostic device, the labeling should additionally satisfy the requirements of 21 CFR 809.10. Generally, the term “labeling” includes the device label, instructions for use, and any patient labeling. See also Labeling Requirements, and device specific guidance, where available, for more information about labeling your device.

If identical materials are used in a predicate with the same type and duration of patient contact, you may identify the predicate in lieu of performing biocompatibility testing and state that your device is comprised of identical materials and that are processed by identical manufacturing methods. This is most appropriate if you are the manufacturer of the predicate and you have complete documentation with respect to the manufacturing methods and materials employed.

17. Electromagnetic Compatibility and Electrical Safety

If your device design includes an electronic component , we recommend that you evaluate its electromagnetic compatibility (EMC). EMC encompasses both emissions (interference with electronic products) and immunity (interference with device performance created by emissions from other electronic products). We recommend you test your device according to IEC 60601-1- 2 Medical Electrical Equipment -- Part 1: General Requirements for Safety; Electromagnetic Compatibility -- Requirements and Tests (Second Edition, 2001) or equivalent method to demonstrate the EMC characteristics of your device.

18. Performance Testing – Bench

If you submit bench test results to support substantial equivalence, we recommend you include the following information in this section. If the device is an in vitro diagnostic device, refer to Appendix B.

You should describe the bench testing and provide the results that support the performance characteristics of your device. Generally, all submissions should include the information below; however, if a relevant device-specific guidance is available, you should follow the recommendations in that guidance document.

list the specific bench tests conducted

describe each test protocol

summarize the results

describe your analysis

discuss your conclusions

The description of test protocols should identify the:

objective of the test

test articles used in the test

test methods and procedures (including any specific test conditions)

study endpoint, i.e., the specific parameter measured

pre-defined acceptance or pass/fail criteria.

In the summary of your results and analysis, we recommend that you briefly present the data derived from testing in a clear and concise form, such as a table.

We also recommend that your conclusions describe any comparison testing with the predicate in terms of substantial equivalence.

19. Performance Testing – Animal

If you submit animal test results to support substantial equivalence, we recommend you include the following information in this section. If the device is an in vitro diagnostic device, refer to Appendix B.

If you conducted animal testing, we recommend that you describe the tests and provide the results that support the performance characteristics of your device. Generally, all submissions that describe animal testing should include the information below; however, if a relevant device-specific guidance is available, you should follow the recommendations in that guidance document. The branch or team responsible for the review of your device is also available to assist you with any questions about animal testing.

list the specific animal tests conducted

describe each test protocol

summarize the results

describe your analysis

discuss your conclusions

The description of test protocols should identify the:

objective of the test

test articles used in the test

test methods and procedures (including any specific test conditions)

study endpoint, i.e., the specific parameter measured

pre-defined acceptance or pass/fail criteria.

In the summary of your results and analysis, we recommend that you briefly present the data derived from testing in a clear and concise form, such as a table.

We also recommend that your conclusions describe any comparison testing with the predicate device in terms of substantial equivalence.

20. Performance Testing – Clinical

If you submit results from clinical studies to demonstrate substantial equivalence, we recommend you include the following information in this section. If the device is an in vitro diagnostic device, refer to Appendix B.

FDA will always consider alternatives to clinical studies when the proposed alternatives are supported by an adequate scientific rationale. Our recommendations for clinical testing typically depend on many factors including device type, intended use, design, safety profile, and clinical experience.

Generally, all submissions that describe clinical studies should include the information below; however, if a relevant device-specific guidance is available, you should follow the recommendations in that guidance document. The branch or team responsible for the review of your device is also available to assist you with any questions about studies.

If your submission describes clinical studies, we recommend that you provide the clinical protocol that identifies the:

objective of the test

test methods and procedures (including any specific test conditions)

study endpoints (usually both safety and effectiveness)

statistical methodology used.

In addition, we recommend that you discuss the study results, analyses performed (including statistical, as appropriate), and conclusions. We also recommend that your conclusions discuss any comparison testing with the predicate device in terms of substantial equivalence.

If your study is considered significant risk5, the study must be conducted under the IDE regulation, 21 CFR Part 812 if it is conducted in the United States.6 If, however, your study is considered non-significant risk, the study is subject to the abbreviated requirements of 21 CFR Part 812.2(b) only.

In all cases, sponsors of clinical trials must comply with the regulations governing institutional review boards (21 CFR Part 56) and informed consent (21 CFR Part 50).

The table below lists the sections we recommend for a Traditional or Abbreviated 510(k) submission. The table also includes related information and additional resources (e.g., links to guidance documents) specific to that section.

Table 2: Sections Recommended in a Traditional or Abbreviated 510(k) and Related Information

identify the submission as a response to a request for additional information to a 510(k);

reference the date of FDA’s request for additional information;

include firm name and 510(k) number; and

identify each question, as it appears in the additional information request followed by a complete response.

Appendix A – 510(k) Cover Letter

Purpose

Traditionally, cover letters have been prepared in a wide range of formats and have varied in terms of the information they contain. This appendix identifies the information we recommend that you include in your cover letter in order to ensure the most efficient review of your submission.

Content

The cover letter should be prepared by the submitter on company letterhead and clearly identify who the submitter is and, if applicable, who is the official contact person authorized by the submitter. The cover letter must include the designation “510(k) Notification” (21 CFR 807.90(e)).

Administrative Information

We recommend that your cover letter identify:

type of 510(k) submission, Abbreviated or Traditional;

your device type in plain terms, i.e., by its common name;

510(k) submitter;

at least one contact person, by name, title, and phone number;

your preference for continued confidentiality (21 CFR 807.95);

your recommended classification regulation;

class (i.e., whether it is unclassified or a class I, II, or III device). For more information regarding classification see “Classify Your Medical Device”. An unclassified device is a legally marketed pre-amendment device for which a classification regulation has yet to be finalized and for which a PMA is not required.;

Your identification of the device classification regulation, classification, panel, or product code for your device may differ from the final classification, panel or product code that appears on FDA’s SE or Not Substantially Equivalent (NSE) determination letter.

Basis for the Submission

We recommend that you explain the basis for your submission. For example, an appropriate basis for a Traditional or Abbreviated 510(k) is a:

new device

modification of a legally marketed device that would not otherwise qualify for a Special 510(k)7

If your device is comprised of finished device components that are assembled into a convenience kit, we recommend that you identify your device as a convenience kit and list all the device components of the kit. See also Convenience Kits Interim Regulatory Guidance. In 510(k) submissions for convenience kits, we recommend that you provide the kit certification statement.

If your device is an in vitro diagnostic device, refer to the OIVD guidance website for the availability of device-specific guidance documents that describe the recommended information on performance characteristics.

Appendix C – Comparison with STED Format

The table below provides a comparison between the document format sections described in the draft STED document as outlined in the FDA guidance document “A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures” and the document format section described in this document. We believe this information will be useful to you if you are preparing a STED 510(k) submission.